<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20110527006611N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-12</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the Effect of Interval, Continuous and combined Aerobic Exercise on Liver Enzymes and Metabolic Syndrome in Overweight Type 2 Diabetic Patients with Nonalcoholic Fatty Liver</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the Effect of Interval, Continuous and combined Aerobic Exercise on Liver Enzymes, IGF-1  and Insulin Hormone and Metabolic Syndrome in Overweight Type 2 Diabetic Patients with Nonalcoholic Fatty Liver</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40902</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients were classified according to fatty liver grade and then randomly divided into 4 groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetes- Non-alcoholic fatty liver disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  interval aerobic exercise - The interval aerobic exercise group performed exercise on a stationary bike for two months, three days a week, with an intensity of 75 to 80 percent of maximum heart rate. Intervention 2: Intervention group: Continuous aerobic exercise - The Continuous aerobic exercise group performed exercise on a stationary bike for two months, three days a week, with an intensity of 60 to 75 percent of maximum heart rate. Intervention 3: Intervention group: Combined aerobic exercise - The combined aerobic exercise group performed exercise on a stationary bike for two months, three days a week, and in between sessions (continuous aerobic exercise and periodic aerobic exercise). Intervention 4: Control group: No regular exercise.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The informed consent form will be available to others without mentioning the names of the participants. Details of the study process are also provided in detail in the file format.

When:
Start of the 8 month period after the research

To whom:
For university students and students in research related fields

Conditions:
There are no specific conditions to provide such information.

Where to obtain:
Zahra Bayat

How to obtain:
Send message to the person responsible for providing the data

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Bayat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kish International Campus, University of Tehran, Niyayesh St., Mirmohanna Blvd., Kish Island, Iran.</address>
        <city>kish</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>79416-55665</zip>
        <telephone>00987644433661-2</telephone>
        <email>z.bayat@ut.ac.ir</email>
        <affiliation>The University of Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Nuri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kish International Campus, University of Tehran, Niyayesh St., Mirmohanna Blvd., Kish Island, Iran</address>
        <city>kish</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>79416-55665</zip>
        <telephone>00987644433661-2</telephone>
        <email>nuri_r7@ut.ac.ir</email>
        <affiliation>University of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Subjects are type 2 diabetic women with non-alcoholic fatty liver.
They are non-insulin-dependent
They use oral medications for treatment (glibenclamide and metformin and sulfonylurease).
The maximum blood glycosylated hemoglobin is 11%.
The minimum history of diabetes is 1 year and the maximum history of diabetes is 15 years</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patients have retinopathy, nephropathy and severe neuropathy.
Have a history of cardiovascular disease and musculoskeletal disorders
Severe musculoskeletal problems that restrict physical activity</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11-K76.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>K76.0: Nonalcoholic fatty liver disease [NAFLD]-E11: Type 2 diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  interval aerobic exercise - The interval aerobic exercise group performed exercise on a stationary bike for two months, three days a week, with an intensity of 75 to 80 percent of maximum heart rate.</i_keyword>
      <i_keyword>Intervention group: Continuous aerobic exercise - The Continuous aerobic exercise group performed exercise on a stationary bike for two months, three days a week, with an intensity of 60 to 75 percent of maximum heart rate.</i_keyword>
      <i_keyword>Intervention group: Combined aerobic exercise - The combined aerobic exercise group performed exercise on a stationary bike for two months, three days a week, and in between sessions (continuous aerobic exercise and periodic aerobic exercise).</i_keyword>
      <i_keyword>Control group: No regular exercise</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Alanine Aminotransferase enzyme. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Blood test with BioSystems kit.</prim_outcome>
      <prim_outcome>Aspartate Aminotransferase enzyme. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Blood test with BioSystems kit.</prim_outcome>
      <prim_outcome>Alkaline phosphatase enzyme. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Blood test with BioSystems kit.</prim_outcome>
      <prim_outcome>Glycosylated hemoglobin. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Blood test with Pishtaz Teb kit.</prim_outcome>
      <prim_outcome>HDL Cholesterol. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Blood test with BioSystems kit.</prim_outcome>
      <prim_outcome>LDL Cholesterol. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Blood test with BioSystems kit.</prim_outcome>
      <prim_outcome>Cholesterol. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Blood test with BioSystems kit.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Blood test with BioSystems kit.</prim_outcome>
      <prim_outcome>Waist circumference. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Standard tape meter.</prim_outcome>
      <prim_outcome>Blood Pressure. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: brachial digital blood pressure monitor.</prim_outcome>
      <prim_outcome>Fasting blood glucose. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Blood test with BioSystems kit.</prim_outcome>
      <prim_outcome>IGF-1 Hormone. Timepoint: At the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Blood test with DiaSorin kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>University of Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-08</approval_date>
        <contact_name>Ethics Committee of Sport Sciences Research Institute</contact_name>
        <contact_address>No. 3, 5th Alley, Miremad Street, Motahhari Street, tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
